Gantenerumab

DGAP-News: MorphoSys' Licensing Partner Roche Received Breakthrough Therapy Designation for Gantenerumab in Alzheimer's Disease

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Monday, October 11, 2021
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MorphoSys AG (FSE: MOR; NASDAQ: MOR) announced today that its licensing partner Roche (SIX: RO, ROG; OTCQX: RHHBY) received Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) for gantenerumab , an anti-amyloid beta antibody developed for subcutaneous administration, for the treatment of people living with Alzheimer's disease (AD).

Key Points: 
  • MorphoSys AG (FSE: MOR; NASDAQ: MOR) announced today that its licensing partner Roche (SIX: RO, ROG; OTCQX: RHHBY) received Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) for gantenerumab , an anti-amyloid beta antibody developed for subcutaneous administration, for the treatment of people living with Alzheimer's disease (AD).
  • Roche is evaluating the safety and efficacy of gantenerumab in these two pivotal trials with more than 2,000 participants for more than two years.
  • Gantenerumab is an investigational IgG1 antibody designed to bind to aggregated forms of beta-amyloid and remove brain amyloid plaques, a pathological hallmark of Alzheimer's disease (AD).
  • Under the terms of the licencing agreement, Roche is fully responsible for the clinical development and potential commercialisation of gantenerumab.

Ad hoc announcement pursuant to Art. 53 LR: Genentech’s Anti-Amyloid Beta Antibody Gantenerumab Granted FDA Breakthrough Therapy Designation in Alzheimer’s Disease

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Friday, October 8, 2021
FDA, Seniors, Public Relations, Investor Relations, Communications, Clinical Trials, Biotechnology, Health, Consumer, Pharmaceutical, Brain, Autism, Public health, Open Road, Behavior, Dementia, Roche, Gantenerumab, Memory, Caregiver, OLE, Biotechnology, Food, Lists of diseases, Neuroscience, Safety, Industry, HIV disease progression rates, Hoffmann-La Roche, Oles, Breakthrough therapy, ADAD, FDA, Review, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Multiple sclerosis, RO, Hope, Alzheimer's disease, ROG, Stroke, Language, Scarlet, Road, Science, Disease, Patient, Research, Organization, Marguerite, Immunoglobulin G, PD, Biomarker, Pharmaceutical industry, Medical imaging, FDA, Seniors, Public Relations, Investor Relations, Communications, Clinical Trials, Biotechnology, Health, Consumer, Pharmaceutical, gantenerumab and its clinical program, Genentech and Roche in Alzheimer’s disease, Genentech in neuroscience, Genentech, GANTENERUMAB AND ITS CLINICAL PROGRAM, GENENTECH AND ROCHE IN ALZHEIMER’S DISEASE, GENENTECH IN NEUROSCIENCE, GENENTECH

This Breakthrough Therapy Designation reinforces our confidence in gantenerumab, which would be the first subcutaneous medicine for the treatment of Alzheimers disease with the potential for at-home administration.

Key Points: 
  • This Breakthrough Therapy Designation reinforces our confidence in gantenerumab, which would be the first subcutaneous medicine for the treatment of Alzheimers disease with the potential for at-home administration.
  • This designation for gantenerumab marks the 39th Breakthrough Therapy Designation for Genentechs portfolio of medicines.
  • Gantenerumab is an investigational IgG1 antibody designed to bind to aggregated forms of amyloid beta and remove brain amyloid plaques, a pathological hallmark of Alzheimers disease (AD).
  • GRADUATION, an open-label study to evaluate the pharmacodynamic (PD) effects of once weekly administration of gantenerumab in participants with early AD.

Eisai presented latest data from the lecanemab clinical program at AAIC 2021

Retrieved on: 
Friday, July 30, 2021
Branches of biology, Amyloidosis, Monoclonal antibodies, Biology, Health sciences, Alzheimer's disease, Lecanemab, Clinical trial, Amyloid beta, Amyloid, Crenezumab, Gantenerumab

The presentations included the latest data for the investigational anti-amyloid beta antibody lecanemab (BAN2401), for which the FDA recently granted Breakthrough Therapy designation.

Key Points: 
  • The presentations included the latest data for the investigational anti-amyloid beta antibody lecanemab (BAN2401), for which the FDA recently granted Breakthrough Therapy designation.
  • In an oral presentation, baseline characteristics and results from the preliminary screening of the Phase 3 clinical study, AHEAD 3-45, for preclinical (asymptomatic) Alzheimer's disease, were presented.
  • For the first time, clinical outcome data from a small cohort of the large Phase 2b open label extension study were presented.
  • "It's very encouraging to see that Eisai's broad clinical program for lecanemab continues to deliver data in support of the effects on both amyloid in the brain and cognitive outcomes.

Eisai presented latest data from the lecanemab clinical program at AAIC 2021

Retrieved on: 
Friday, July 30, 2021
Branches of biology, Amyloidosis, Monoclonal antibodies, Biology, Health sciences, Alzheimer's disease, Lecanemab, Clinical trial, Amyloid beta, Amyloid, Crenezumab, Gantenerumab

The presentations included the latest data for the investigational anti-amyloid beta antibody lecanemab (BAN2401), for which the FDA recently granted Breakthrough Therapy designation.

Key Points: 
  • The presentations included the latest data for the investigational anti-amyloid beta antibody lecanemab (BAN2401), for which the FDA recently granted Breakthrough Therapy designation.
  • In an oral presentation, baseline characteristics and results from the preliminary screening of the Phase 3 clinical study, AHEAD 3-45, for preclinical (asymptomatic) Alzheimer's disease, were presented.
  • For the first time, clinical outcome data from a small cohort of the large Phase 2b open label extension study were presented.
  • "It's very encouraging to see that Eisai's broad clinical program for lecanemab continues to deliver data in support of the effects on both amyloid in the brain and cognitive outcomes.

Peer-Reviewed Scientific Publication Profiles First Wave of Disease-Modifying Alzheimer’s Treatments with Potential for Near Term Approval: Aducanumab, Gantenerumab, BAN2401 and ALZ-801

Retrieved on: 
Monday, August 17, 2020
Mental health, Health, Genetics, Clinical trials, Pharmaceutical, Biotechnology, Monoclonal antibodies, Health, Clinical medicine, Medicine, Alzheimer's disease, Aducanumab, BAN2401, Clinical trial, Gantenerumab, Alzheon, ALZ-801, Alzheon

This positions ALZ-801 to potentially become the first oral disease-modifying agent for patients and healthy people at high risk for Alzheimers disease.

Key Points: 
  • This positions ALZ-801 to potentially become the first oral disease-modifying agent for patients and healthy people at high risk for Alzheimers disease.
  • With the need for disease-modifying treatments for Alzheimers patients greater than ever, we are optimistic that one or more of these agents will become available to patients in the near future.
  • The publication profiles four anti-amyloid treatments that have progressed to late-stage clinical trials for Alzheimers disease, in spite of clinical trial failures across the class of amyloid-targeted drugs in AD.
  • The four agents are the injectable antibodies aducanumab, gantenerumab, and BAN2401, and a small molecule oral tablet, ALZ-801.